Tsingke Highlights AI-Driven CLDN18.2 Antibody Discovery at AIS 2026

On July 8, 2026 Tsingke, a provider of integrated life science research solutions, participated in the Antibody Industrial Symposium (AIS) 2026, one of Europe’s leading conferences dedicated to therapeutic antibodies and biotherapeutics. At the event, the company presented its latest advances in AI-assisted therapeutic antibody discovery and showcased its comprehensive antibody development platform at Booth #44.

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AI-Enabled Discovery of Highly Selective CLDN18.2 Antibodies

As part of the scientific program, Tsingke presented an AI-enabled workflow for discovering therapeutic antibodies targeting Claudin 18.2 (CLDN18.2), an emerging target for gastric cancer and other solid tumors.

The presentation demonstrated how AI-assisted sequence analysis and a proprietary screening strategy improve target specificity by reducing potential cross-reactivity with the closely related CLDN18.1 protein, a longstanding challenge in CLDN18.2 antibody development.

The resulting antibody candidates showed strong specificity and favorable developability, highlighting the potential of integrating AI with experimental validation to accelerate therapeutic antibody and antibody-drug conjugate (ADC) development.

End-to-End Antibody Development Capabilities

In addition to its scientific presentation, Tsingke showcased its integrated antibody development platform, covering multiple stages of biologics discovery and development, including:

Antibody Discovery using hybridoma, single B-cell, and phage display technologies for the identification of high-affinity and highly specific antibodies.
Antibody Engineering including antibody humanization, affinity maturation, and synthetic antibody library construction to accelerate therapeutic antibody optimization.
Protein Expression supported by six expression systems and a rapid gene-to-protein workflow for applications including monoclonal antibodies, ADCs, AOCs, and in vitro diagnostics (IVD).
"AIS 2026 provided an excellent opportunity to share our latest work in AI-enabled antibody discovery and connect with researchers across the antibody community," said Chuanting Tan, Senior R&D Engineer at Tsingke. "As therapeutic antibody development becomes increasingly complex, integrating computational approaches with experimental validation can help researchers identify and optimize promising candidates more efficiently. We will continue to enhance our discovery and development capabilities to support innovation in biologics research."

Building on these efforts, Tsingke will continue expanding its AI-enabled discovery platform and integrated biologics capabilities to help researchers accelerate projects from early target discovery through protein expression and characterization.

(Press release, Tsingke Biotech, JUL 8, 2026, View Source;302820198.html [SID1234669111])

Northwest Biotherapeutics Presents Updated Survival Data from Phase III Trial of DCVax®-L For Glioblastoma Using Individual Patient Level Data in Multiple Independent Analyses

On July 8, 2026 Northwest Biotherapeutics (OTCQB:NWBO) (the "Company" or "NWBio"), a biotechnology company developing DCVax personalized immune therapies for solid tumor cancers, reported that the Company’s Chief Technical Officer, Dr. Marnix Bosch, presented updated survival data from the Phase III trial of DCVax-L for glioblastoma (GBM) at the 2026 Annual Meeting of the British Neuro-Oncology Society (BNOS). The updated data included results of multiple different statistical analyses conducted by independent statisticians, using individual patient-level data (IPD), and demonstrated that the survival extension with DCVax-L was likely underestimated in the original analysis of the trial results.

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The original analysis of the DCVax-L trial results used cohort-level data to compare the results in DCVax-L patients vs. controls, as the Company only had access to cohort-level data for the controls. More recently, the Company obtained individual patient data (IPD) from several major randomized controlled trials (RCTs) in newly diagnosed glioblastoma (ndGBM), which enabled more precise matching of the DCVax-L patients and the controls. Notably, the Statistical Analysis Plan (SAP) for the DCVax-L trial had envisioned that IPD-based analyses would be undertaken when access to IPD could be obtained.

Two widely recognized and rigorous statistical methods were applied by the independent statisticians for the IPD-based analyses: propensity score matching (PSM) and inverse probability weighting (IPW). The PSM analyses of two large RCTs in ndGBM found that the median survival advantage with DCVax-L treatment was 4.9 to 6.3 months, and PSM analysis of a third RCT in ndGBM found 3.4 to 3.7 months survival advantage with DCVax-L. The Hazard Ratios (HRs) ranged from 0.69 to 0.77, and the p values ranged from 0.004 to 0.027. All of these results are substantially greater than the results of the original trial analysis, which found that the median survival advantage with DCVax-L was 2.8 months based on cohort-level data.

The IPW analyses, taking a different approach than the PSM analyses, delivered similar findings: median survival advantage with DCVax-L of 3.4 to 4.3 months.

In addition to conducting the PSM and IPW analyses of known prognostic factors, the statisticians also conducted two forms of sensitivity analyses to check for potential unknown factors which could have confounded or biased the results: E Values and Rosenbaum’s Gamma measures. The results of these sensitivity analyses demonstrated that the observed treatment effect with DCVax-L is not attributable to a hidden imbalance between the DCVax-L patients and the controls.

For further information, please see the presentation slide deck on the Company’s website (www.nwbio.com)

"These new PSM and IPW analyses, together with the E Value and Rosenbaum’s Gamma sensitivity analyses, provide strong evidence and reinforcement of the survival benefit with DCVax-L treatment, based on my review of the statisticians’ analyses," commented Dr. Marnix Bosch. "The key is that all of these analyses, which have taken multiple different approaches and have applied them to multiple ndGBM RCTs, have produced results that are all directionally consistent and all in the same range of magnitude. The statisticians’ findings indicate that the median survival benefit reported from the original analysis of the DCVax-L Phase III trial, based on cohort-level data, was likely substantially underestimated."

(Press release, Northwest Biotherapeutics, JUL 8, 2026, View Source [SID1234669110])

HanchorBio Tests Broader Ambitions for HCB101 Through InxMed Partnership

On July 8, 2026 HanchorBio, Inc. (TWSE: 7827) reported step to broaden the development path for HCB101, its lead oncology asset, through a new partnership with InxMed.

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The Taiwan-listed clinical-stage biotech announced that its subsidiary, FBD Biologics Limited, has signed a strategic memorandum of understanding (MOU) with InxMed (Shanghai) Co., Ltd., a late-stage biotechnology company focused on cancer drug resistance and tumor microenvironment biology.

Under the MOU, the two companies will conduct preclinical and translational research evaluating HCB101 in combination with InxMed’s investigational assets, including IN10018/ifebemtinib, a FAK inhibitor, and OMTX705, a FAP-targeted antibody-drug conjugate.

For investors, the agreement is not a near-term revenue event. No licensing economics, upfront payment, or clinical trial commitment has been disclosed. The significance is strategic: HanchorBio is testing whether HCB101 can move beyond its current clinical anchors and become a broader combination asset for difficult-to-treat solid tumors.

HCB101 is a clinical-stage SIRPα-Fc fusion protein targeting the CD47/SIRPα pathway, designed to enhance macrophage-mediated anti-tumor activity. HanchorBio has been developing the asset with gastric cancer as an important clinical anchor, while also exploring other solid tumors, including head and neck cancer and colorectal cancer.

InxMed brings a complementary profile. Its lead asset, IN10018/ifebemtinib, has advanced into late-stage clinical development, including a Phase III trial in China for platinum-resistant recurrent ovarian cancer, and has received Fast Track designation from the U.S. FDA. Its pipeline focuses on tumor defense mechanisms, including FAK signaling, cancer-associated fibroblasts, and stromal barriers.

The collaboration gives HanchorBio a way to test whether HCB101’s macrophage-centered immune activation can be paired with drugs targeting the tumor’s physical and biological defenses, including fibrosis, stromal barriers, and immune exclusion.

That fits HanchorBio’s broader "anchor-and-expand" strategy: use defined tumor settings, such as gastric cancer, to establish clinical value, then evaluate whether the same mechanism can be extended to other biologically selected solid tumors.

The next key question is whether the collaboration can generate translational data strong enough to support additional development decisions. If it does, the MOU could help HanchorBio strengthen HCB101’s positioning as a potential combination backbone and reinforce the value of its FBDB platform.

For now, the InxMed partnership should be viewed as a measured strategic expansion move — not a financial milestone, but a test of how far HCB101’s value can extend beyond its initial clinical path.

(Press release, Hanchor Bio, JUL 8, 2026, View Source [SID1234669109])

Study of Ensartinib as Postoperative Adjuvant Therapy Published in The New England Journal of Medicine

On July 8, 2026 Betta Pharmaceuticals reported ensartinib as postoperative adjuvant therapy for patients with stage IB–IIIB (T3N2M0) ALK-positive non-small cell lung cancer (NSCLC), known as the ELEVATE study, was published online in full in The New England Journal of Medicine (NEJM; Impact Factor 84.5), a world-leading medical journal. The study provides important evidence for adjuvant therapy of ALK-positive NSCLC worldwide and has the potential to change current clinical practice.

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Lung cancer is the most common and deadliest malignancy both globally and in China. According to the statistical report issued by the National Cancer Center, in 2022, there were an estimated 1.06 million new cases of lung cancer and 733,300 related deaths in China. Of patients with lung cancer, NSCLC accounts for up to 85%. Approximately 5-7% of patients with NSCLC have ALK-positive disease. Although some patients with ALK-positive NSCLC are diagnosed at an early or intermediate stage amenable to surgical resection, they still face high risks of recurrence and death, and traditional postoperative adjuvant chemotherapy offers modest benefits. Therefore, reducing the risk of recurrence and prolonging survival after surgery remains an urgent unmet clinical need.

The ELEVATE study directly addresses this unmet need. In the ELEVATE study, a total of 274 patients from 56 medical centers across China were randomly assigned at a 1:1 ratio to receive oral ensartinib or placebo following complete surgical resection and any planned adjuvant chemotherapy. It is a phase 3, multicenter, randomized, placebo-controlled, double-blind registration study in the field of ALK-TKI adjuvant therapy for ALK-positive lung cancer. The results showed a 2-year disease-free survival rate of 86.4% in the ensartinib group compared with 53.5% in the placebo group, with a hazard ratio of 0.20 (95% CI: 0.11 to 0.38) in patients with stage II to IIIB NSCLC. This means that two years of adjuvant treatment with ensartinib reduces the risk of disease recurrence or death by 80%. A significant reduction in this risk was also observed in stage IB to IIIB population, with a hazard ratio of 0.20 (95% CI: 0.10 to 0.37).

Dr. Ding Lieming, Chairman and CEO of Betta Pharmaceuticals, stated: "The publication of the ELEVATE study in NEJM represents high recognition from the international medical community of the scientific value and clinical significance of this research. It is not only an important milestone for Betta but also a landmark achievement showcasing Chinese clinical oncology research on the global academic stage, with the potential to change postoperative adjuvant treatment strategies for patients with ALK-positive lung cancer. The marketing application for the adjuvant indication of ensartinib has already been accepted in China. Moving forward, we will continue to focus on unmet clinical needs, deepen independent innovation, and accelerate the development of more innovative products with core competitiveness and global impact, benefiting more patients."

It is known that ensartinib is a novel, potent, and highly selective next-generation ALK inhibitor. It is an innovative drug developed independently and wholly owned by Betta Pharmaceuticals and its subsidiary Xcovery. Its first-line and second-line indications have already been approved in China, offering good accessibility and a favorable safety profile, and it has received the First Prize for Scientific and Technological Progress in Zhejiang Province. In December 2024, ensartinib was approved for marketing in the United States and subsequently included in the NCCN Guidelines for Non-Small Cell Lung Cancer. Marketing authorization applications in other overseas markets, including the European Union, are progressing.

(Press release, Betta Pharmaceuticals, JUL 8, 2026, View Source [SID1234669108])

UroGen Announces FDA Clearance of the IND for UGN-501, an Investigational Next-Generation Oncolytic Virus for Non-Muscle Invasive Bladder Cancer

On July 8, 2026 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported that the U.S. Food and Drug Administration (FDA) cleared the Company’s Investigational New Drug application (IND) for UGN-501, a next-generation investigational oncolytic virus. The IND clearance enables initiation of a planned Phase 1 clinical study in patients with non-muscle invasive bladder cancer (NMIBC). The Phase 1 study is expected to begin in Q4 2026 and will evaluate the safety, tolerability, and feasibility of intravesical administration of UGN-501.

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"Patients with non-muscle invasive bladder cancer continue to face a significant risk of disease recurrence despite available treatment options," said Mark Schoenberg, M.D., Chief Medical Officer of UroGen. "UGN-501 is an investigational next-generation oncolytic virus designed to selectively destroy tumor cells while generating an anti-tumor immune response. FDA clearance of the IND allows us to begin evaluating whether the encouraging nonclinical profile of UGN-501 can translate into a safe and meaningful therapeutic approach for patients with NMIBC. We look forward to initiating the Phase 1 study and advancing our efforts to develop innovative treatment options for patients with bladder cancer."

NMIBC continues to present significant clinical challenges, particularly among patients whose disease recurs following standard treatment. Despite available therapies, recurrence rates remain substantial, underscoring the need for novel bladder-sparing therapeutic approaches. UroGen believes UGN-501’s differentiated mechanism of action and local administration strategy may offer a promising new approach for addressing this unmet need.

About UGN-501

UGN-501 is an investigational, next-generation oncolytic virus being investigated for the treatment of non-muscle invasive bladder cancer (NMIBC). UGN-501 is designed to selectively replicate within tumor cells, resulting in direct tumor cell destruction and an anti-tumor immune response. The program is supported by nonclinical data demonstrating cytotoxic activity across a broad panel of bladder cancer cell lines representing multiple stages and grades of disease. While UGN-501 is initially being developed for bladder cancer, the Company believes UGN-501’s underlying properties may have broader applicability across additional solid tumor indications and intends to evaluate future development opportunities based on emerging clinical and translational data.

(Press release, UroGen Pharma, JUL 8, 2026, View Source [SID1234669107])